|- candidate number||2186|
|- NTR Number||NTR724|
|- Date ISRCTN created||26-sep-2006|
|- date ISRCTN requested||13-sep-2006|
|- Date Registered NTR||31-jul-2006|
|- Secondary IDs||P02-089 |
|- Public Title||ICAD: Clinical validation study of a new algorithm for oral anticoagualant dosing.|
|- Scientific Title||ICAD: Clinical validation study of a new algorithm for oral anticoagualant dosing.|
|- hypothesis||The equations used by most current algorithms are usually based on a simple pharmacodynamic model, which implies a linear function between the INR and the dosage. Our new algorithm consists of two sub models in which the first sub model describes the collective influence of all processes on the effect of the vitamin K antagonist and the second sub model describes the relationship between the dosage and the corresponding INR. The second sub model includes a variable parameter to reflect the sensitivity of the patient that may change over time. Because of the inclusion of a parameter which relfects the sensitivity of the patient we think it is better capable of proposing a doasage wich leads to an INR within the therapeutic range.|
|- Healt Condition(s) or Problem(s) studied||Anticoagulants, Indications|
|- Inclusion criteria||1. Indication for longterm anticoagulant therapy;|
2. Age between 18 and 80.
|- Exclusion criteria||1. Paticipation in the patient selfmanagement program;|
2. Staying long periods abroad;
3. Terminal stage of disease.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||14-aug-2003|
|- planned closingdate||1-sep-2004|
|- Target number of participants||712|
|- Interventions||Oral anticoagulant dosage supported by the new algorithm (ICAD) and oral anticoagulant dosage supported by the algorithm TRODIS.|
|- Primary outcome||Percentage of time therapeutic range, proportion of visits in shich the algorithm gave a proposal and the proportion that was accepted by the physician.|
|- Secondary outcome||1. Mean time between visits;|
2. Bleeding events;
3. Thrombotic events.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. Y. Leeuwen, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. F.R. Rosendaal|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Departement of Clinical Epidemiology|
(Source(s) of Monetary or Material Support)
|Dutch Thrombosis Foundation, Foundation Bazis|
|- Publications||1. J Thromb Haemost. 2007 Aug;5(8):1644-9. Epub 2007 May 7. |
2. Pasterkamp E, Kruithof CJ, Van der Meer FJ, Rosendaal FR, Vanderschoot JP. A model-based algorithm for the monitoring of long-term anticoagulation therapy. J Thromb Haemost. 2005;3:915-921.
|- Brief summary||Introduction:|
Oral anticoagulants are among the most widely used drugs and have a sizable risk of severe bleeding complications. Efforts to improve dosing quality in oral anticoagulant control include the use of computer algorithms. Since the current algorithms are simplistic and give dosage proposals in a small fraction of patients, we developed an algorithm based on principles of system and control engineering that gives proposals in nearly all patients.
To evaluate the new algorithm in clinical practice.
Design, Setting and Participants:
This is adouble-blind randomized controlled trial among patients with an indication for long-term anticoagulant treatment at the Leiden Anticoagulation Clinic. There are two interventions: oral anticoagulant dosing supported by the new algorithm (ICAD) or oral anticoagulant dosing by the standard algorithm (TRODIS).
Main outcome measures are the percentage of time in therapeutic range, proportion of visits in which the algorithm gave a proposal and the proportion of proposals that was accepted by the physicians.
|- Main changes (audit trail)|
|- RECORD||31-jul-2006 - 16-jun-2008|